BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL AORTIC BIOPROSTHESIS

    MDR report key: 1060702 · Received June 10, 2008

    Report

    Report Number
    6000002-2008-07511
    Event Type
    Death
    Date Received
    June 10, 2008
    Date of Event
    April 13, 2008
    Report Date
    May 12, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED AFTER AN IMPLANT DURATION OF APPROX TWO MONTHS, DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON RSR PERICARDIAL AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2800TFX R-07J1897

    Patients

    Seq Age Sex Outcome Treatment
    1 Death